As of 1 January 2022, “combined review” is the way all new Clinical Trials of an Investigational Medicinal Product (CTIMP) applications must be made in the United Kingdom (UK).
TMC is happy to announce we have supported our first client using this new submission approach to obtain both Regulatory Agency (RA) and Research Ethics Committee (REC) approvals in one combined review, together with the Health Research Authority (HRA) approval for NHS hospitals.
Following great collaboration with our client and Chief Coordinating Investigator, the TMC team was able to achieve an impressive timeline of just 9 weeks from submission to full (RA, REC and HRA) approval. This will have the positive benefit of shortening set-up times in the UK and allowing rare disease patients to access important drugs as part of a clinical trial.
Further information on the UK’s new “combined review” process came be found here.
If you are planning a new clinical trial in the UK, please reach out to us about using this new process